(41 days)
The Olympus XENF-DP Rhino-Laryngofiberscope, its accessories and ancillary equipment have been designed to be used with an Olympus Light Source, documentation equipment, display monitor and other ancillary equipment for endoscopic diagnosis within the upper airway which includes the nasal cavity, nasopharynx, hyporpharynx and larynx.
This subject device "XENF-DP Rhino-Laryngofiberscope" is used for observation within nasal and nasopharyngeal lumen. This endoscope enables use of 2 types of light sources, a detachable single use battery light source powered and a light cable light source.
This 510(k) summary (K011869) for the XENF-DP Rhino-Laryngofiberscope does not contain information about acceptance criteria or a study proving that the device meets such criteria.
Instead, the submission relies on substantial equivalence to predicate devices. This means the manufacturer is asserting that their new device is as safe and effective as a legally marketed device (predicate device) and therefore does not require new clinical studies to prove safety and effectiveness.
Here's why and what information is missing:
- Reason for not requiring clinical data: The document explicitly states under section "G. Reason for not requiring clinical data": "When compared to the predicate devices, "XENF-DP Rhino-Laryngofiberscope" does not incorporate any significant change for safety and efficacy to the predicate device. Observation within nasal and nasopharyngeal lumen has been done widely, and established its safety and effectiveness, therefore clinical data is not necessary for its evaluation of its safety and efficacy."
Therefore, I cannot provide the requested information in the table or answer the specific questions about studies, sample sizes, ground truth, or expert involvement because this information is not present in the provided 510(k) summary. The submission focuses on device design, materials, intended use, and technological characteristics, and compares them to predicate devices to establish substantial equivalence, rather than providing data from a new study against acceptance criteria.
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.